pravastatin sodium

Generic: pravastatin sodium

Labeler: aphena pharma solutions - tennessee, llc
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name pravastatin sodium
Generic Name pravastatin sodium
Labeler aphena pharma solutions - tennessee, llc
Dosage Form TABLET
Routes
ORAL
Active Ingredients

pravastatin sodium 40 mg/1

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC

Identifiers & Regulatory

Product NDC 71610-884
Product ID 71610-884_308dc3a4-51ba-ebd0-e063-6294a90acb99
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209869
Listing Expiration 2026-12-31
Marketing Start 2018-04-13

Pharmacologic Class

Classes
hmg-coa reductase inhibitor [epc] hydroxymethylglutaryl-coa reductase inhibitors [moa]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 71610884
Hyphenated Format 71610-884

Supplemental Identifiers

RxCUI
904475
UNII
3M8608UQ61

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name pravastatin sodium (source: ndc)
Generic Name pravastatin sodium (source: ndc)
Application Number ANDA209869 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 40 mg/1
source: ndc
Packaging
  • 45 TABLET in 1 BOTTLE (71610-884-45)
  • 60 TABLET in 1 BOTTLE (71610-884-53)
  • 90 TABLET in 1 BOTTLE (71610-884-60)
source: ndc

Packages (3)

71610-884-45 45 TABLET in 1 BOTTLE (71610-884-45) 71610-884-53 60 TABLET in 1 BOTTLE (71610-884-53) 71610-884-60 90 TABLET in 1 BOTTLE (71610-884-60)

Ingredients (1)

pravastatin sodium (40 mg/1)

Linked Drug Pages (1)

PRAVASTATIN SODIUM ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "308dc3a4-51ba-ebd0-e063-6294a90acb99", "openfda": {"unii": ["3M8608UQ61"], "rxcui": ["904475"], "spl_set_id": ["308db0cc-0deb-99b6-e063-6394a90a9b74"], "manufacturer_name": ["Aphena Pharma Solutions - Tennessee, LLC"]}, "finished": true, "packaging": [{"sample": false, "description": "45 TABLET in 1 BOTTLE (71610-884-45)", "package_ndc": "71610-884-45", "marketing_start_date": "20250313"}, {"sample": false, "description": "60 TABLET in 1 BOTTLE (71610-884-53)", "package_ndc": "71610-884-53", "marketing_start_date": "20250313"}, {"sample": false, "description": "90 TABLET in 1 BOTTLE (71610-884-60)", "package_ndc": "71610-884-60", "marketing_start_date": "20250313"}], "brand_name": "PRAVASTATIN SODIUM", "product_id": "71610-884_308dc3a4-51ba-ebd0-e063-6294a90acb99", "dosage_form": "TABLET", "pharm_class": ["HMG-CoA Reductase Inhibitor [EPC]", "Hydroxymethylglutaryl-CoA Reductase Inhibitors [MoA]"], "product_ndc": "71610-884", "generic_name": "PRAVASTATIN SODIUM", "labeler_name": "Aphena Pharma Solutions - Tennessee, LLC", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "PRAVASTATIN SODIUM", "active_ingredients": [{"name": "PRAVASTATIN SODIUM", "strength": "40 mg/1"}], "application_number": "ANDA209869", "marketing_category": "ANDA", "marketing_start_date": "20180413", "listing_expiration_date": "20261231"}